FDA limits research of former AHA president for submitting false information

Janice Hopkins Tanne, New York

Just days before he completed his year as president of the American Heart Association on 30 June, Dr David Faxon signed aconsent agreement with the Food and Drug Administration limitinghis clinicalresearch.

On 19 June 2002 Dr Faxon agreed that for three years he would not be the principal investigator for more than two FDA regulatedclinical investigations at any one time, and that he would notbe the principal clinical investigator for a study that enrolledmore than 25subjects.

The agreement follows an investigation into Dr Faxon`s work, which was held from October to November in 1999 when he was chiefof cardiology at the University of Southern California in LosAngeles. The FDA inspected his clinical study, comparing a newdrug with aspirin to see which gave better protection from ischaemicheart events after acute coronarysyndromes.

After its investigation, the FDA complained that Dr Faxon failed to personally conduct or supervise the clinical investigation,that he submitted false information to the trial sponsor, andthat he failed to conduct the study in accordance with the approvedprotocol. He was also found not to have kept adequate and accuratecase histories and not to have provided a Spanish version of theinformed consent document to people whose first language was Spanish,notEnglish.

The complaint cited examples of records being falsified to alter the duration of chest pain; changes in the records that ledto the inclusion of patients who were not eligible for inclusion;patients being included despite being enrolled after the timelimits; patients being included when they were receiving drugsthat should have excludedthem.

Dr Faxon answered the FDA in December 1999, saying his study`s coordinator was responsible for misrepresentation of data andhe had no knowledge of the practice. The FDA rejected his response:"We remind you that you are responsible for personally conductingand supervising the clinical investigations since you are theinvestigator of record. Therefore, we consider your explanationunacceptable."

In April 2000, the FDA sent Dr Faxon a "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)."Few clinical investigators receive such a notice. In 2000, DrFaxon was one of only six to receive one. In 2001 there were four,and so far this year there have beentwo.

In July 2000, Dr Faxon became section chief of cardiology and professor of medicine at the University of Chicago